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Study Detail

Wen, L. M., Baur, L. A., Simpson, J. M., Rissel, C., & Flood, V. M. (2011). Effectiveness of an early intervention on infant feeding practices and "tummy time": A randomized controlled trial. Archives of Pediatrics & Adolescent Medicine, 165(8), 701-707.

Program(s) Reviewed: Healthy Beginnings

Study Screening Details

Screening DecisionScreening Conclusion
Study Passes ScreensEligible for Review

Study Design Details

RatingDesignAttritionBaseline EquivalenceReassignmentConfounding Factors
ModerateRCTLowNot established on race or SES; no outcome measures assessable at baseline.NoNo
Notes:

This randomized controlled trial had low attrition, no confounding factors, and no reassignment; it qualifies for a moderate rating in the HomVEE review. A high rating requires that authors statistically control for any baseline differences in race/ethnicity, socioeconomic status (SES), or measures of the outcome. Because the study authors do not indicate that they assessed race/ethnicity of the study sample, nor do they indicate that their analysis controls for this or any other variables, moderate is the highest possible rating for the study.

Study Characteristics

Study Participants Evaluators randomly assigned pregnant women receiving prenatal care through two hospitals to intervention or control groups (with women from each hospital in each study group). The study enrolled 337 women in the intervention group and 330 women in the control group. Most women were assessed and randomized before giving birth (61 percent); however, the remaining cases were assessed and randomized shortly after giving birth. Evaluators examined outcomes 6 and 12 months after the child's birth. At 6 months, the authors analyzed 561 women (278 intervention, 283 control); at the 12-month follow-up, they analyzed 527 women (268 intervention, 259 control). Among the original randomized sample, the plurality of women (42 percent) were younger than age 25; most (54 percent) were either employed or on maternity leave, and most (55 percent) had a high school or technical diploma before the study began. Among these women, about one-third earned less than $40,000 annually; one-third earned $40,000 to $79,999; and one-third earned $80,000 or more. Authors did not report collecting race/ethnicity data but stated that 64 percent of women in the study were born in Australia.
Setting The study was conducted in southwestern Sydney, Australia, through Liverpool and Campbelltown Hospitals, and enrolled women in the study in 2007 and 2008.
Home Visiting Services The intervention group received up to six visits in the first year: at 30 to 36 weeks of pregnancy (if recruited at that time); and 1, 3, 5, 9, and 12 months after birth. (A later study by these authors reports a subsequent 24-month visit). Each visit lasted about 1 to 2 hours. Working with the mother and infant, the nurse addressed infant feeding practices, nutrition and play/activity (of both child and family), and social support. Using a checklist, nurses followed a protocol for service delivery, with discussion points and resources.
Comparison Condition The control group received the usual services provided in Australia, which includes home visiting from a childhood nursing service within one month of the child's birth. The study provided home safety promotion materials at 6 and 12 months.
Staff Characteristics and Training Home visiting staff were community nurses. They received training on the intervention by health promotion practitioners. No additional information is provided on the characteristics or training.
Funding Source The study was funded by the Australian National Health and Medical Research Council (ID number 393112) as part of the Healthy Beginnings Trial
Author Affiliation The authors are affiliated with the University of Sydney and the University of Wollongong. The first authors are also affiliated with the Health Promotion Service, which sponsors the Healthy Beginnings Trial program model.

Study Registration

Clinicaltrials.gov Identifier: None found; listed as Australian Clinical Trial Registry No. 12607000168459. Study registration was assessed by HomVEE beginning with the 2014 review.

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